Trial Title:
Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Head and Neck Cancer to Prevent Aspiration Pneumonia
NCT ID:
NCT01598402
Condition:
Head and Neck Cancer
Conditions: Official terms:
Pneumonia
Pneumonia, Aspiration
Head and Neck Neoplasms
Amoxicillin
Clavulanic Acids
Clavulanic Acid
Conditions: Keywords:
LAHNC
Locally Advanced Head and Neck Cancer
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
amoxicillin/clavulanic acid suspension
Description:
625 mg tid, start day 29 after the start of CRT until 14 days after the end of CRT
Arm group label:
prophylactic treatment
Other name:
The total duration of the use of amoxicillin /clavulanic acid suspension will be between 20 and 27 days.
Summary:
Patients with locally advanced head and neck cancer treated with chemo-radiotherapy have
(during and shortly after this treatment) a high risk of developing pneumonia by
aspiration. This pneumonia is often associated with a hospital admission and affects the
quality of life.
The purpose of the study, is to determine whether prophylactic antibiotics may decrease
the development of pneumonia. Prophylactic antibiotics means that there are no signs of
pneumonia are already
Detailed description:
Concomitant chemoradiotherapy (CRT) is used in locally advanced head and neck cancer
(LAHNC). It will be administered to patients for unresectable disease or for organ
preservation as primary treatment. Furthermore, it can be used as postoperative treatment
in case high risk recurrent disease is present. This treatment induces a high rate of
acute toxicity, such as mucositis, dermatitis, dysphagia, anorexia, and pain. Swallowing
dysfunction and aspiration are seen in a high proportion (30%-100%) of patients and with
an immense impact on Quality of life (QoL).
Around half of the patients will develop an aspiration pneumonia during or shortly after
the treatment.
Patients, who develop fever during concomitant chemoradiotherapy, are most of the time
admitted in the hospital. In the differential diagnosis pneumonia is on the first place
in all those patients. The standard diagnostic procedures consist of a chest X-ray and
culture of the sputum and blood. Pneumonia can lead to mortality in this frail patient
group.
The treatment of patients treated with chemoradiotherapy who develop fever and have a
definite or suspected pneumonia, is administration of antibiotics, most frequently
intravenous amoxicillin/clavulanic acid.
LAHNC patients who are smoking and/or with malnutrition are at the highest risk of
getting a pneumonia during or after radiotherapy. Because smoking is one of the risk
factors of developing head and neck cancer chronic obstructive pulmonary disease (COPD)
is frequently present in this group. Also, COPD is a known risk factor for developing
pneumonias.
Aspiration is seen in all primary sites of head and neck cancer, sometimes it is seen
more frequently in patients with cancer of the larynx and hypopharynx. No data of
prophylactic administration of antibiotics are available in LAHNC patients. However, a
Cochrane review was published to assess the effects of prophylactic antibiotic regimens
for the prevention of respiratory tract infections(RTIs) and overall mortality in adults
receiving intensive care.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with LAHNC which will be treated with CRT as discussed by a
multidisciplinary team (i.e. a head and neck surgeon, a medical oncologist, and a
radiation oncologist). This can be CRT as primary treatment or postoperative CRT.
- Written informed consent
- Expected adequacy of follow-up
Exclusion Criteria:
- Patients with pneumonia within the last 14 days before start of CRT
- Patients with other infections within the last 14 days within the last 14 days
before start of CRT
- Patients with use of maintenance antibiotics
- Patients with antibiotic treatment within the last 14 days before start of CRT
- Patients with an allergy on amoxicillin
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ziekenhuis Rijnstate
Address:
City:
Arnhem
Zip:
6800 TA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
J. Blaisse, Md
Phone:
+31 26-3788888
Email:
jblaiss@alysis.nl
Contact backup:
Last name:
S. Brouwer
Phone:
+31 26-3788888
Email:
sbrouwer@rijnstate.nl
Investigator:
Last name:
J. Blaisse, Md
Email:
Principal Investigator
Facility:
Name:
University Medical Center Nijmegen st Radboud
Address:
City:
Nijmegen
Zip:
6525 GH
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
C. van Herpen, Md
Phone:
+31 24 361 03 53
Email:
c.vanherpen@onco.umcn.nl
Contact backup:
Last name:
C. Driessen, drs
Phone:
+31 24 361 11 11
Phone ext:
pager 3438
Email:
c.driessen@onco.umcn.nl
Investigator:
Last name:
C.M.L van Herpen, Md, Phd
Email:
Principal Investigator
Investigator:
Last name:
C. Driessen, drs
Email:
Sub-Investigator
Facility:
Name:
Medisch Centrum Alkmaar
Address:
City:
Alkmaar
Zip:
1815 JD
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
C. Smorenburg, Md
Phone:
+31 72-5484444
Email:
c.h.smorenburg@mca.nl
Contact backup:
Last name:
M. Komen
Phone:
+31 72-5484444
Email:
manon.komen@mca.nl
Investigator:
Last name:
C. Smorenburg, Md
Email:
Principal Investigator
Facility:
Name:
University Medical Centre Groningen
Address:
City:
Groningen
Zip:
9700 RB
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
J. Gietema, Md
Phone:
+31 50 361 61 61
Email:
j.a.gietema@med.umcg.nl
Contact backup:
Last name:
G. Sieling
Phone:
+31 50 361 61 61
Email:
g.c.m.sieling@umcg.nl
Investigator:
Last name:
J. Gietema, Md
Email:
Principal Investigator
Facility:
Name:
Medisch centrum Leeuwarden
Address:
City:
Leeuwarden
Zip:
8934 AD
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
E. Fiets, Md
Phone:
+31 58-2866666
Email:
edward.fiets@znb.nl
Contact backup:
Last name:
T. Rienks
Phone:
+31 58-2866666
Email:
tineke.rienks@znb.nl
Investigator:
Last name:
E. Fiets, Md
Email:
Principal Investigator
Facility:
Name:
Academical Hospital Maastricht (AZM)
Address:
City:
Maastricht
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Email:
ann.hoeben@mumc.nl
Investigator:
Last name:
A. Hoeben, PhD
Email:
Principal Investigator
Start date:
December 2011
Completion date:
December 2014
Lead sponsor:
Agency:
Radboud University Medical Center
Agency class:
Other
Source:
Radboud University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01598402
